RML recalls 10 drug batches after quality failures, defects: The wider industry impact

The emergence of CCTV footage has added a fresh dimension to the case

New Delhi: Medicines such as sodium valproate, spironolactone, imipramine, metoprolol and methyl ergometrine — used to treat seizures, heart conditions, depression and postpartum bleeding — have been pulled from use at Dr Ram Manohar Lohia Hospital after 10 batches were either found to be “Not of Standard Quality” or reported to have physical defects.

The hospital’s inventory management section directed departments and wards to immediately stop using the affected batches and return them to the respective drug units, according to four notices issued between Sept 7 and 14. These included sodium valproate gastro-resistant 200 mg, spironolactone 50 mg and imipramine 25 mg. In a notice dated Sept 9, the hospital reported that isosorbide mononitrate 20 mg tablets were found in powder form within the strip. The affected batch, ABT6711, was manufactured by Glowson India Labs Pvt Ltd, with a manufacturing date of July 2026 and expiry date of June 2028. A similar defect was reported in metoprolol 50 mg tablets in a Sept 7 notice. The Sept 14 recall notices asked departments to return the affected batches to the drug units by Sept 18, while the notices on the defective tablets instructed departments to return the medicines within three days with proper documentation.

The hospital said as of now, no severe adverse effect had been reported by end users in relation to the affected medicines.

In a notice dated Sept 14, the hospital’s oral and topical drug unit said three tablet batches had failed analytical testing and were found to be “Not of Standard Quality”. The same day, the hospital’s injectable drug unit issued an urgent recall for five batches of injectable medicines after they too failed analytical testing and were declared “Not of Standard Quality”. The hospital said tablets from batch ABT6608, also manufactured by Glowson India Labs Pvt Ltd, were found in powder form within the strip, and ordered their withdrawal and return. The situation is being closely monitored and all necessary measures are being taken in accordance with established drug quality and patient-safety protocols,” an RML official said.

The medicines included adenosine, methyl ergometrine, multivitamin injection, pheniramine maleate and ascorbic acid. The notices also flagged physical defects in two batches of tablets. Departments were asked to stop using the batch and return it to the store within three days. “The hospital has made interim arrangements to ensure the availability of alternative medicines and avoid any disruption in patient care.

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